DEERFIELD, IL — Brintellix (vortioxetine) has been approved by the Food and Drug Administration to treat adults with major depressive disorder (MDD).
“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Mitchell Mathis, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression.”
The efficacy of Brintellix in treating depression was demonstrated in six clinical studies in which adults with MDD were randomly assigned to receive Brintellix or placebo, with an additional study indicating that Brintellix decreased the likelihood of participants becoming depressed again after treatment of their MDD episode.
In the clinical trials, the most common side effects reported by participants taking Brintellix were nausea, constipation and vomiting.
Brintellix, which will be available in 5 mg, 10 mg, 15 mg and 20 mg tablets, and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and healthcare professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults ages 18 to 24 during initial treatment.
An increased risk of suicidal thoughts and behavior has not been identified for adults older than 24, according to studies, and adults ages 65 and older appear to have a reduced risk. Still, the FDA cautions that patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.
Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, IL.
“There are very few new antidepressant drugs currently in development, even though so many patients still struggle with depression. We are excited about the approval of Brintellix and being able to offer a new option for patients,” said Anders Gersel Pedersen, executive vice president and head, Research and Development at Lundbeck. “This approval continues our six-decade history of innovation in research and treatments for brain disorders, and underscores the commitment of the Takeda and Lundbeck partnership to bring forward new treatments for depression.”